Systane Ultra Solution/ Drops
FDA Label NDC 0065-1431

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Alcon Laboratories, Inc. for the product Systane Ultra (NDC 0065-1431). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Purpose

Active IngredientsPurpose
Polyethylene Glycol 400 0.4%Lubricant
Propylene Glycol 0.3%Lubricant
Active IngredientsPurpose
Polyethylene Glycol 400 0.4%Lubricant
Propylene Glycol 0.3%Lubricant

Uses

  • For the temporary relief of burning and irritation due to dryness of the eye
    • For the temporary relief of burning and irritation due to dryness of the eye
      • for the temporary relief of burning and irritation due to dryness of the eye
      • for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun

Warnings

For external use only                 

For external use only.

For external use only

Do Not Use

  • if this product changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product
    • if this product changes color or becomes cloudy
    • if you are sensitive to any ingredient in this product
      • if this product changes color or becomes cloudy
      • if you are sensitive to any ingredient in this product

When Using This Product

  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use
    • do not touch tip of container to any surface to avoid contamination
    • replace cap after each use
      • do not touch tip of container to any surface to avoid contamination
      • replace cap after each use

Stop Use And Ask A Doctor If

you experience any of the following:

  • eye pain
  • changes in vision 
  • continued redness or irritation of the eye
  • condition worsens or persists for more than 72 hours
    • you feel eye pain
    • changes in vision occur
    • redness or irritation of the eye(s) gets worse, persists or lasts more than 72 hours

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • shake well before using 
  • put 1 or 2 drops in the affected eye(s) as needed
    • Shake well before using.
      • shake well before using
      • put 1 or 2 drops in the affected eye(s) as needed

Other Information

  • store at room temperature
    • Instill 1 or 2 drops in the affected eye(s) as needed.
    • Store at room temperature.
      • store at room temperature

Inactive Ingredients

aminomethylpropanol, boric acid, hydroxypropyl guar, POLYQUAD* (polyquarternium-1) 0.001% preservative, potassium chloride, purified water, sodium chloride, sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Aminomethylpropanol, boric acid, hydroxypropyl guar, POLYQUAD® (polyquaternium-1) 0.001% preservative, potassium chloride, purified water, sodium chloride, sorbitol.  May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

aminomethylpropanol, boric acid, hydroxypropyl guar, POLYQUAD® (polyquaternium-1) 0.001% preservative, potassium chloride, purified water, sodium chloride, sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Other

Active IngredientsPurpose
Polyethylene Glycol 400 0.4%Lubricant
Propylene Glycol 0.3%Lubricant

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Otc - Stop Use

Stop use and ask a doctor if you experience any of the following:

  • eye pain
  • changes in vision
  • continued redness or irritation of the eye
  • condition worsens or persists for more than 72 hours

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Principal Display Panel

Systane*
ULTRA
LUBRICANT EYE DROPS

HIGH PERFORMANCE

EXTENDED PROTECTION
FAST SYMPTOM RELIEF

#1 Doctor
Recommended
Dry Eye Brand†

Alcon®
STERILE
3 mL (0.1 FL OZ)

Systane® ULTRA
LUBRICANT EYE DROPS

HIGH PERFORMANCE
EXTENDED PROTECTION
FAST SYMPTOM RELIEF

#1 Doctor Recommended Brand1

Alcon
STERILE
3mL (0.1 FL OZ)

Carton (Carton)

Carton (Carton)

Systane® ULTRA
LUBRICANT EYE DROPS

HIGH PERFORMANCE
EXTENDED PROTECTION
FAST SYMPTOM RELIEF

#1 Doctor Recommended Brand1

Alcon
STERILE 
10  mL (⅓ FL OZ)

Systane® 
LUBRICANT EYE DROPS

ULTRA
HIGH PERFORMING DRY EYE RELIEF

Fast-acting hydration and lasting relief

Moisture rich formula

#1 Doctor Recommended Brand1

Alcon

STERILE 

10  mL (1/3 FL OZ)

* Please review the disclaimer below.